Atrophic Vaginitis, Lichen Planus, Lichen Sclerosus, Menopause Related Conditions, Vaginitis
Conditions
Brief summary
The objective of the study is to determine the efficacy of 7-0940 in the management of genital skin conditions in female patients
Interventions
Anecdotal evidence suggests that genital conditions in women associated with vaginal atrophy improve with the use of film-forming silicone dressings.
Sponsors
Stratpharma AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Able to provide informed consent * Diagnosed genital skin condition
Exclusion criteria
* Unable to give informed consent * Patient unable to apply topical device * Allergy or intolerance to ingredients or excipients of the formulation of studied products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| gynaecological skin condition | Duration of the therapy will be according to physician's clinical practice. The average is 3 visits over a period of 3 to 6 months | Likert scales to measure: * Dryness * Tissue thinning * Erosion/Ulcers * Fissures * Erythema * Scarring/adhesion * Contact bleeding * Bloodblisters * Greyish film * White lacy streaks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patient symptoms | Duration of the therapy will be according to physician's clinical practice. The average is 3 visits over a period of 3 to 6 months | Likert scales to measure: * Pruritus/itchiness * Tender/sore * Swelling * Dryness * Burning of skin * Dyspareunia * Stinging with urination/clothes * Defecating pain/burning |
Countries
Australia
Outcome results
None listed